Device product
Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators. The assay provides a rapid screening procedure for presence of the analyte in urine.
Z-1751-2020
Product summary
- Event
- Event 85289
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1610 units
- Official record key
device-enforcement:Z-1751-2020
Official wording
Reason: Cross-reactivity testing may not meet the claims indicated in the Opiate 2000 ng (OP2) Instructions For Use. The presence of certain compounds in urine may result in false positive or false negative patient test results.
Code information: Catalog Number 475006 ; UDI: 15099590222031; Lot Numbers: M904147 and older including M810039, M901087 and M904147) and 4 lots OP2 (M805122, M810039, and M901087. .
Distribution pattern: Distributed throughout the United States and to Puerto Rico. States include: CA, NC, OR, MI, GE, AL, SC, TX, NJ, IA, MS, IN, MA, NC, OH, AZ, LA, MA, NY, PA, KY, WV, MI, WA, CO, IL, VA, FL, KS, MD, ID, DE, NV, OK, AR, HI, WI, NY.
Derived failure modes
-
Unknown
Cross-reactivity testing may not meet the claims indicated in the Opiate 2000 ng (OP2) Instructions For Use. The presence of certain compounds in urine may result in false positive or false negative patient test results.